FujiFilm SonoSite SII User manual

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Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: [phone] or 1-425-951-1200
Fax: [phone]
EC Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH The Hague, The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Rd
Brookvale, New South Wales 2100, Australia
SonoSite SII, SonoHD2, SonoMB, SonoSite and the SONOSITE logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in
various jurisdictions.
DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information.
Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.
FUJIFILM is a registered and unregistered trademark of FUJIFILM Corporation in various jurisdictions.
The FUJIFILM SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: US
8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US 8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US
8,147,408; US 8,137,278; US 8,088,071; US 8,066,642; US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US
7,604,596; US 7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,575,908; US
6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US 6,364,839; US 6,203,498; US 6,135,961; US 5,893,363; US 5,817,024; US
5,782,769; US 5,722,412; AU: 730822; AU: 727381; CA: 2,372,152; CA: 2,371,711; CN 103237499B; CN 101231457B; CN 98108973.9; CN
98106133.8; CN 97113678.5; DE 69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE 602004023816.3; DE 60034670.6;
DE 60029777.2; EP 1589878; EP 1552792; EP 1180971; EP 0875203; EP 0815793; EP 1180970; EP 0881492; ES 2229318; ES 159878; ES
1552792; ES 0881492; FR 158978; FR 1552792; FR 1180970; FR 0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792; GB 1180971;
GB 1180970; GB 0881492; GB 0875203;GB 0815793; IT 1589878; IT 1552792; IT 0881492; IT 0815793; JP 5782428; JP 4696150; KR 532359;
KR 528102; NO 326814; NO 326202 and pending.
P22358-01 3/2016
Copyright © 2016 FUJIFILM SonoSite, Inc.
All rights reserved.
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

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Introduction ........................................................................................1
Audience ..............................................................................................1
Contact Information..............................................................................1
Conventions .........................................................................................2
Labeling symbols..................................................................................2
Specifications.....................................................................................7
System Specifications ..........................................................................7
System Dimensions..............................................................................7
Display Dimensions..............................................................................7
Environmental limits .............................................................................7
Operating (system, battery, and transducer)........................................7
Shipping and storage (system and transducer)....................................7
Shipping and storage (battery) .............................................................7
Electrical specifications ........................................................................7
Battery specifications ...........................................................................8
Imaging Modes.....................................................................................8
Image and Clip Storage........................................................................8
Compatible accessories and peripherals .............................................8
Safety...................................................................................................11
Electrical safety ....................................................................................11
Electrical safety classification...............................................................13
Equipment safety..................................................................................13
Battery safety .......................................................................................14
Clinical safety .......................................................................................15
Hazardous materials ............................................................................15
Electromagnetic compatibility...............................................................16
Electrostatic discharge .........................................................................16
Separation distance..............................................................................17
Guidance and manufacturer’s declaration............................................18
Immunity testing requirements .............................................................21
Standards.............................................................................................21
Electromechanical Safety Standards ...................................................21
EMC Standards Classification..............................................................21
Acoustic standards...............................................................................21
Biocompatibility standards....................................................................21
Airborne Equipment Standards ............................................................22
DICOM Standard..................................................................................22
HIPAA Standard...................................................................................22
System Overview................................................................................23
About the System.................................................................................23
Theory of Operation .............................................................................23
Description of Operating Modes...........................................................25
Additional System Feature Performances............................................26
Front End Overview..............................................................................27
Back End Overview..............................................................................28
Control Subsystem...............................................................................29
Power Supply and Control....................................................................30
Battery Pack (VBAT) ............................................................................30

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Battery Charger.................................................................................... 31
DICOM ................................................................................................. 31
Troubleshooting................................................................................. 33
System and Subsystem Diagnosis....................................................... 33
System Repair...................................................................................... 34
Test Equipment .................................................................................... 34
Failure (Assert) Codes ......................................................................... 34
Verifying a System Assert Code .......................................................... 34
DICOM ................................................................................................. 35
User Interface....................................................................................... 36
Battery.................................................................................................. 36
Replacement Procedures .................................................................. 37
Required Tools..................................................................................... 37
User Interface Removal ....................................................................... 37
Required Parts ..................................................................................... 37
User Interface Removal ....................................................................... 37
User Interface Parts Transfer............................................................... 40
Install User Interface ............................................................................ 42
Base Assembly Disassembly for Repair and/or Replacement............. 43
Required Tools..................................................................................... 44
Power Button PCA Replacement ......................................................... 44
Required Parts ..................................................................................... 44
Power Button PCA Removal ................................................................ 44
Power Button PCA Replacement ......................................................... 44
Back Enclosure Replacement .............................................................. 45
Back Enclosure Removal ..................................................................... 45
Back Enclosure Replacement .............................................................. 45
Internal Mini-Dock Replacement .......................................................... 46
Required Parts ..................................................................................... 46
Internal Mini-Dock Removal ................................................................. 46
Internal Mini-Dock Replacement .......................................................... 47
DTC/STC Replacement ....................................................................... 47
Required Parts ..................................................................................... 47
DTC Removal....................................................................................... 47
DTC Replacement................................................................................ 48
Dual Fan Cable Assembly Replacement ............................................. 49
Required Parts ..................................................................................... 49
Dual Fan Cable Assembly Removal .................................................... 49
Dual Fan Cable Assembly Replacement ............................................. 49
Power Supply PCBA Removal ............................................................. 50
Required Parts ..................................................................................... 50
Power Supply PCBA Removal ............................................................. 50
Power Supply PCBA Replacement ...................................................... 50
SD Card Replacement ......................................................................... 51
Main PCBA Replacement .................................................................... 51
Required Parts ..................................................................................... 51
Main PCBA Removal ........................................................................... 51
Main PCBA Replacement .................................................................... 52

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Mid-Frame Replacement......................................................................53
Required Parts .....................................................................................53
Mid-Frame Replacement......................................................................53
Maintenance........................................................................................55
Periodic Maintenance...........................................................................55
Performance Testing..........................................................................57
Overview ..............................................................................................57
Recommend Test Equipment...............................................................57
Setting Up Performance Tests .............................................................57
Basic Operational Tests .......................................................................58
2D Performance Tests .........................................................................58
2D Performance / Image Quality ..........................................................58
Axial Measurement Accuracy...............................................................59
Lateral Measurement Accuracy............................................................59
Penetration...........................................................................................60
Additional Performance Tests ..............................................................60
Color Doppler (Color) ...........................................................................60
Color Power Doppler (CPD) .................................................................61
M Mode Imaging...................................................................................61
Tissue Harmonic Imaging.....................................................................61
Image Quality Verification Test/Livescan .............................................61
Printer...................................................................................................62
Battery Charging ..................................................................................62
Video Output ........................................................................................62
Replacement Parts List......................................................................63
Base Assembly Components ...............................................................63
Additional Base Assembly Components ..............................................64
User Interface Components .................................................................65
Parts Unique to STC Systems..............................................................66
Enclosure Parts....................................................................................67
Transducer Nest Frame Assembly.......................................................68
Ordering Replacement Parts................................................................68
Service Event Reporting....................................................................69
Service Event Report Form..................................................................70
Service Event Report Instructions ........................................................71
Returning Products to FUJIFILM SonoSite ..........................................72
Shipping Instructions............................................................................72

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Chapter 1: Introduction 1
Chapter 1: Introduction
Before servicing the SonoSite SII ultrasound system, please read this manual.
The ultrasound system has multiple configurations and feature sets. All are described in this service manual
but not every option may apply to your system. System features depend on your system configuration,
transducer, and exam type.
Refer to the SII Ultrasound System User Guide for additional information regarding safety, system controls,
operation, capabilities, and specifications.
Audience
The intended audience of this manual is properly trained field and in-house service personnel.
Contact Information
Questions and comments are encouraged. FUJIFILM SonoSite is interested in your feedback regarding the
service manual. If you encounter difficulty with the system, use the information in this manual to help correct
the problem. If the problem is not covered here, contact FUJIFILM SonoSite Technical Support as follows:
Technical Support (USA, Canada) 1-877-657-8118
Technical Support fax: [phone]
Technical Support e-mail: [email protected]
FUJIFILM SonoSite website: www.sonosite.com
International Technical Support: Contact your local representative or call (USA)
[phone]
European Service Center United Kingdom
Tel: [phone]
e-mail: [email protected]
France
Tel: [phone]
e-mail: [email protected]m
Germany
Tel: [phone]
e-mail: [email protected]m
Spain
Tel: [phone]
e-mail: [email protected]m
Italy
Tel [phone]
e-mail: [email protected]m
Asia/Pacific Tel: [phone]
e-mail: FFSS-APACME-s[email protected]

2Chapter 1: Introduction
Conventions
These conventions are used in this service manual:
•AWARNING describes precautions necessary to prevent injury or loss of life.
•ACaution describes precautions necessary to protect the products.
• Numbered steps must be performed in a specific order.
• Bulleted lists present information in list format but do not imply a sequence.
Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 1: Labeling Symbols
Symbol Definition
Alternating Current (AC)
Class 1 device indicating manufacturer’s declaration of conformance with
Annex VII of 93/42/EEC
Class 1 device requiring verification by the Notified Body of sterilization or
measurement features, or to a Class IIa, IIb, or III device requiring
verification or auditing by the Notified Body to applicable Annex(es) of
93/42/EEC
Attention, see the user guide
Follow instructions for use.
Device complies with relevant Australian regulations for electronic devices.
Batch code, date code, or lot code type of control number
Biological risk
Authorized representative in the European Community
Canadian Standards Association. The “C” and “US” indicators next to this
mark signify that the product has been evaluated to the applicable CSA
and ANSI/UL Standards, for use in Canada and the US, respectively.
Catalog number
LOT
REF

Chapter 1: Introduction 3
Collect separately from other household waste (see European Commission
Directive 93/86/EEC). Refer to local regulations for disposal.
Corrugated recycle
Dangerous voltage
Date of manufacture
Manufacturer
Direct Current (DC)
Do not get wet.
Do not stack over 2 high.
Do not stack over 5 high.
Do not stack over 10 high.
Electrostatic sensitive devices
Device complies with relevant FCC regulations for electronic devices.
Fragile
GEL Gel
Sterilized using irradiation
Table 1: Labeling Symbols (Continued)
Symbol Definition
STERILE R

4Chapter 1: Introduction
Sterilized using ethylene oxide
Hot
Indoor use only.
Non-ionizing radiation
Paper recycle
Serial number type of control number
Temperature limitation
Atmospheric pressure limitation
Humidity limitation
Submersible. Protected against the effects of temporary immersion.
Water-Tight Equipment. Protected against the effects of extended
immersion.
Handle transducer with care.
To avoid tipping, do not move the system using the handle on the front of
the SonoSite SII ultrasound system.
When moving the system, push the stand using the tray assembly.
Type BF patient applied part
(B = body, F = floating applied part)
Defibrillator proof type CF patient applied part
A mandatory action that the user shall read the accompanying
documentation for more information.
Table 1: Labeling Symbols (Continued)
Symbol Definition
STERILE EO
SN